The Role
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.”
Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide.
In this individual contributor role, you will serve as a critical quality reviewer within QC Bioassay Laboratories, ensuring the accuracy, integrity, and timely release of data supporting molecular and cell based assays.
You will combine technical depth, investigative rigor, and strong GxP discipline to maintain audit readiness and operational excellence across laboratory systems and documentation.
Through mentorship, continuous improvement leadership, and digital enablement—including exposure to advanced analytics and generative AI driven tools—you will help strengthen QC performance and data reliability at scale.
Here’s What You’ll Do:
Review executed QC test records for molecular and cell based assays to ensure accuracy, compliance with Good Documentation Practices (GDPs), and adherence to Data Integrity requirements.
Ensure documentation, data, and records are complete, accurate, and maintained in a state of inspection readiness to support business needs and regulatory audits.
Understand and acquire knowledge to effectively navigate associated laboratory software systems and equipment interfaces, enabling thorough and technically sound record review.
Review reagent and equipment logbooks to verify traceability, compliance, and operational consistency.
Follow all relevant GxP regulations, guidelines, and company policies to ensure full compliance with regulatory and internal requirements.
Execute tasks precisely as defined in internal guiding documents, including but not limited to SOPs and work instructions.
Write and revise SOPs and reports to ensure clarity, technical accuracy, and regulatory alignment.
Support internal and external audits, including audit preparation activities and direct support during inspections.
Assist with audit preparation and broader regulatory compliance initiatives.
Utilize strong investigative skills to identify, assess, and resolve issues within laboratory operations, driving effective root cause analysis and corrective actions.
Assist with troubleshooting issues as applicable to ensure minimal disruption to laboratory operations.
Lead and organize continuous improvement projects to enhance laboratory efficiency, documentation quality, compliance posture, and operational effectiveness.
Work directly with management to ensure QC goals and milestones are met, proactively identifying risks and mitigation strategies.
Perform on the job (OJT) training and act as a mentor to QC Bioassay staff, including mentoring and training junior team members.
Foster a positive and inclusive work culture that promotes collaboration, innovation, accountability, and continuous improvement.
Complete all required training and assigned learning plans according to defined due dates and prescribed requalification cadence.
Embrace digital tools and opportunities to leverage advanced analytics and generative AI enabled solutions to enhance documentation review, trend analysis, deviation investigations, and overall laboratory performance.
Perform additional duties as assigned in support of QC Bioassay operations.
The key Moderna Mindsets you’ll need to succeed in the role:
We obsess over learning. We don’t have to be the smartest we have to learn the fastest.
We behave like owners. The solutions we’re building go beyond any job description.
Here’s What You’ll Need (Basic Qualifications)
BA/BS Degree
Bachelors of Science (STEM degree) with minimum 5 years of experience in a cGMP laboratory, or a Master of Science (STEM degree) with minimum 3 years of experience in a cGMP laboratory and with hands-on experience in molecular biology, Cell based Assays and Protein Analysis. Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review
Specific Certifications or Training: None
Other Quantifiable Preference:
Working knowledge of USP, ISO, FDA and ICH guidelines
Familiarity with laboratory information systems
Working knowledge of ALCOA principles
At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-TR2-